Chronic total occlusion crossing devices with imaging

ABSTRACT

An imaging device includes a hollow flexible shaft having a central longitudinal axis and an imaging window therein. An optical fiber extends within the hollow flexible shaft substantially along the central axis. A distal tip of the optical fiber is attached to the hollow flexible shaft and aligned with the imaging window so as to transfer an optical coherence tomography signal through the imaging window. A handle is attached to the hollow flexible shaft configured rotate the hollow flexible shaft at speeds of greater than 1,000 rpm.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND

Peripheral artery disease (PAD) and coronary artery disease (CAD) affectmillions of people in the United States alone. PAD and CAD are silent,dangerous diseases that can have catastrophic consequences when leftuntreated. CAD is the leading cause of death for in the United Stateswhile PAD is the leading cause of amputation in patients over 50 and isresponsible for approximately 160,000 amputations in the United Stateseach year.

Coronary artery disease (CAD) and Peripheral artery disease (PAD) areboth caused by the progressive narrowing of the blood vessels most oftencaused by atherosclerosis, the collection of plaque or a fatty substancealong the inner lining of the artery wall. Over time, this substancehardens and thickens, which may interfere with blood circulation to thearms, legs, stomach and kidneys. This narrowing forms an occlusion,completely or partially restricting flow through the artery. Bloodcirculation to the brain and heart may be reduced, increasing the riskfor stroke and heart disease.

Interventional treatments for CAD and PAD may include endarterectomyand/or atherectomy. Endarterectomy is surgical removal of plaque fromthe blocked artery to restore or improve blood flow. Endovasculartherapies such as atherectomy are typically minimally invasivetechniques that open or widen arteries that have become narrowed orblocked. Other treatments may include angioplasty to open the artery.For example, a balloon angioplasty typically involves insertion of acatheter into a leg or arm artery and positioning the catheter such thatthe balloon resides within the blockage. The balloon, connected to thecatheter, is expanded to open the artery. Surgeons may then place a wiremesh tube, called a stent, at the area of blockage to keep the arteryopen.

Such minimally invasive techniques (e.g., atherectomy, angioplasty,etc.) typically involve the placement of a guidewire through theocclusion. Using the guidewire, one or more interventional devices maybe positioned to remove or displace the occlusion. Unfortunately,placement of the guidewire, while critical for effective treatment, maybe difficult. In particular, when placing a guidewire across anocclusion, it may be difficult to pass the guidewire through theocclusion while avoiding damage to the artery. For example, it is oftendifficult to prevent the guidewire from directing out of the lumen intothe adventitia and surrounding tissues, potentially damaging the vesseland preventing effective treatment of the occlusion.

As a result, occlusion-crossing devices, intended to assist in thepassing of the guidewire through the occlusion, have been developed.Many of the devices, however, are ill equipped to be used with imaging,thereby making placement of the guidewire cumbersome and difficult.Moreover, many of the occlusion-crossing devices are too large to beused in small-diameter peripheral arteries or in coronary arteries.

Accordingly, occlusion crossing catheter devices designed to addresssome of these concerns are described herein.

SUMMARY OF THE DISCLOSURE

Described herein are occlusion-crossing devices having a low profile soas to be usable in small vessels, such as coronary arteries.

In general, in one embodiment, an imaging device includes a hollowflexible shaft having a central longitudinal axis and an imaging windowtherein. An optical fiber extends within the hollow flexible shaftsubstantially along the central axis. A distal tip of the optical fiberis attached to the hollow flexible shaft and aligned with the imagingwindow so as to transfer an optical coherence tomography signal throughthe imaging window. A handle is attached to the hollow flexible shaftconfigured rotate the hollow flexible shaft at speeds of greater than1,000 rpm.

This and other embodiments may include one or more of the followingfeatures. The optical fiber can extend substantially along the centralaxis for the entire length of the fiber. The device can be less than 0.1inches, 0.08 inches, or 0.05 inches in diameter. The hollow flexibleshaft can be made of tungsten. The hollow flexible shaft can be made ofmultiple layers of wound filars. The filars can be counterwound. Thehollow flexible shaft can further include a mirror therein configured toreflect light from the optical fiber into adjacent tissue. The devicecan include an outer sheath extending around the hollow flexible shaft.The outer sheath can include an optically clear annular section at thedistal end thereof.

In general, in one embodiment, an imaging assembly includes a catheterhaving a cutter and a lumen extending the length of the catheter. Ahollow flexible shaft is configured to be inserted within the lumen ofthe catheter. The hollow flexible shaft includes a central longitudinalaxis and an imaging window therein. An optical fiber extends within thehollow flexible shaft substantially along the central axis. A distal tipof the optical fiber is attached to the hollow flexible shaft andaligned with the imaging window so as to transfer an optical coherencetomography signal through the imaging window.

This and other embodiments can include one or more of the followingfeatures. The catheter can include a cutter at a distal end. The hollowflexible shaft can further include a handle attached thereto configuredrotate the hollow flexible shaft at speeds of greater than 1,000 rpm.The optical fiber can extend substantially along the central axis forthe entire length of the fiber. The imaging assembly can further includean outer sheath extending around the hollow flexible shaft. The outersheath can include an optically clear annular section at the distal endthereof. The hollow flexible shaft can be made of tungsten. The hollowflexible shaft can be made of multiple layers of wound filars. Thefilars can be counterwound. The hollow flexible shaft can furtherinclude a mirror attached to the distal end configured to reflect lightfrom the optical fiber into adjacent tissue.

In general, in one embodiment, a method of imaging a body lumenincludes: inserting a catheter into the body lumen; inserting an imagingdevice into a lumen of the catheter, the imaging device including ahollow flexible shaft having a central longitudinal axis with an imagingwindow therein and an optical fiber extending within the hollow flexibleshaft and attached to the hollow flexible shaft , the optical fiberextending substantially along the central longitudinal axis; rotatingthe hollow flexible shaft within the lumen of the catheter; andcollecting images of the body lumen through the imaging window with theoptical fiber.

This and other embodiments can include one or more of the followingfeatures. Rotating the hollow flexible shaft within the lumen caninclude rotating the hollow flexible shaft at speeds of greater than1,000 rpm. Collecting images of the body lumen can include collectingimages of the body lumen at rates of greater than 10 frames per minute.The body lumen can be a coronary artery or a peripheral artery. Thecatheter can include a cutter thereon, and the method can furtherinclude cutting tissue of the body lumen with the catheter to passthrough an occlusion in the body lumen. The method can further includeremoving the imaging device from the lumen of the catheter and advancinga guidewire through the lumen of the catheter after passing the cutterthrough the occlusion.

In general, in one embodiment, an occlusion crossing device includes arotatable hollow flexible shaft having a central longitudinal axis andan imaging window therein. The occlusion crossing device furtherincludes an optical fiber extending within the hollow flexible shaftsubstantially along the central axis. A distal tip of the optical fiberis aligned with the imaging window so as to transfer an opticalcoherence tomography signal through the imaging window. A cutter isattached to a distal end of the hollow flexible shaft.

This and other embodiments can include one or more of the followingfeatures. The optical fiber can extend substantially along the centralaxis for the entire length of the fiber. The occlusion crossing devicecan further include an outer sheath extending around the hollow flexibleshaft. A monorail guidewire can be attached to the outer sheath. Theouter sheath can include an optically clear annular section at thedistal end thereof. The hollow flexible shaft can be made of tungsten.The hollow flexible shaft can be made of multiple layers of woundfilars. The filars can be counterwound. The device can be less than 0.1,less than 0.08, or less than 0.05 inches in diameter. The cutter caninclude a fluted distal end. The cutter can further include a slantedproximal end and a mirror attached to the proximal end configured toreflect light from the optical fiber into adjacent tissue. The opticalfiber can be configured to remain stationary relative to the hollowflexible shaft. The optical fiber can be attached to the hollow flexibleshaft and configured to rotate therewith. The occlusion crossing devicecan further include a handle attached to the flexible shaft configuredto rotate the hollow flexible shaft at speeds of greater than 1,000 rpm.

In general, in one embodiment, a method of crossing an occlusion in ablood vessel includes: inserting an occlusion crossing device into thevessel, the occlusion crossing device including a hollow flexible shafthaving a central longitudinal axis and an imaging window therein, anoptical fiber extending within the hollow flexible shaft substantiallyalong the central axis to transfer an optical coherence tomographysignal, and a cutter attached to a distal end of the hollow flexibleshaft; rotating the hollow flexible shaft and cutter so as to separatetissue of the occlusion; collecting images of the vessel through theimaging window with the optical fiber; and passing the cutter throughthe occlusion.

This and other embodiments can include one or more of the followingfeatures. Rotating the flexible shaft and cutter can include rotating atspeeds of greater than 1,000 rpm. Collecting images of the vessel caninclude collecting images at rates of greater than 10 frames per minute.The method can further include rotating the optical fiber with thehollow flexible shaft. Rotating the hollow flexible shaft can includerotating the imaging shaft while keeping the fiber rotationally fixed.The vessel can be a coronary artery or a peripheral artery.

In general, in one embodiment, an occlusion crossing device includes anelongate body and a drive shaft extending through the elongate bodyhaving a perforating tip attached thereto. The occlusion crossing devicefurther includes a deflectable tip having a wedged distal end attachedto the elongate body and a guidewire lumen extending through thedeflectable tip.

This and other embodiments can include one or more of the followingfeatures. The occlusion crossing device can further include an imagingelement attached to the drive shaft. The imaging element can be anoptical coherence tomography imaging element. The deflectable tip can beconfigured to be deflected by axial movement of the drive shaft. Thedevice can be less than 0.1 inches, less than 0.08 inches, or less than0.05 inches in diameter.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A-1C show an occlusion crossing device having an optical fiberfor imaging running down the center of the device. FIG. 1A shows anouter view of the device. FIG. 1B shows a close-up of the imaging andcutting portion of the device of FIG. 1A. FIG. 1C is a cross-section ofthe device of FIG. 1A.

FIGS. 1D-1E show exemplary cutting tips for use with the device of FIG.1A.

FIG. 2A shows placement of the device of FIGS. 1A-1C in a passiveconfiguration in a vessel. FIG. 2B shows placement of the device ofFIGS. 1A-1C in an active configuration in a vessel.

FIGS. 3A-3B show a handle for use with the device of FIGS. 1A-1C. FIG.3A is an outer view of the handle. FIG. 3B is a cross-section of thehandle.

FIG. 4A shows a cross-section of an exemplary occlusion crossing devicehaving a stationary optical fiber and rotating outer sheath. FIG. 4Bshows the device of FIG. 4A with an outer sheath therearound.

FIGS. 5A-5E show an exemplary occlusion crossing device with adeflectable wedged distal tip. FIG. 5A shows a cross-section of thedevice with the deflectable tip in a closed configuration. FIG. 5B showsa cross-section of the device with the deflectable tip in an openconfiguration. FIG. 5C shows a cross-section of the device with thedeflectable tip in an open configuration and the cutting edge extendeddistally. FIG. 5D is an end-view of the deflectable tip. FIG. 5E is anisometric view of the deflectable tip.

DETAILED DESCRIPTION

Described herein are occlusion-crossing devices having a low profile soas to be usable in small-diameter arteries and coronary arteries. Ingeneral, the devices described herein can have on-board imaging, such asoptical coherence tomography (OCT) imaging. The optical fiber for theOCT imaging can substantially along the central of the device, therebydecreasing the profile of the device and allowing for single directionrotation at high speeds. A monorail guidewire lumen can be attached tothe devices described herein.

In some embodiments, a catheter device, such as an occlusion-crossingdevice, can include an imaging shaft with a fiber running down thecenter of the catheter. The fiber can be rotated with a fiber opticjunction so as to rotatable at high speeds in a single direction. Amonorail guidewire lumen can extend along the outside of the deviceparallel to the central axis of the catheter.

Referring to FIGS. 1A-1C, an exemplary catheter device 100 is shown. Thecatheter device 100 can include an imaging shaft 122. The imaging shaft122 can be hollow and can have an inner diameter of approximately 0.005″to 0.010″, e.g., 0.009″ or 0.008″. The imaging shaft 122 could have anouter diameter of approximately 0.01-0.038″. Further, the imaging shaft122 can be sized to work inside the lumen of another catheter, e.g., acatheter having a lumen diameter of 0.014″, 0.018″, or 0.035″. In someembodiments, the imaging shaft 122 can be made of a wire material, suchas stainless steel or tungsten, or, alternatively can be made from aflexible tube such as a plastic or laser cut tube. Further, in someembodiments, the imaging shaft 122 can include multiple filar layers.For example, the imaging shaft 122 can include two layers of 8counterwound filars per layer or three layers of 12 counterwound filarsper layer or the number of filars could vary by layer (e.g., 12 filarsover 8 filars). Advantageously, by using multiple layers of filars, theimaging shaft 122 can be configured to rotate at speeds of over 1,000rpm.

The catheter 100 can further include an imaging element. Thus, anoptical fiber 197 can extend through the hollow imaging shaft 122 suchthat the optical fiber 197 runs substantially along the central axis ofthe catheter for the entire length of the fiber 197. The fiber 197 canbe attached at the distal end of the imaging shaft 122 (such as in thebulb 198 described below), but can be otherwise free to float within theimaging shaft 122. The imaging fiber 197 can transfer an opticalcoherence tomography (OCT) signal for imaging of the vessel in which thedevice 100 is placed. In some embodiments, the imaging fiber 197 canhave a polyimide coating therearound within the length of the shaft 122to support and protect the fiber 197 as it spins within the shaft 122.

The optical fiber 197 can end in a hollow bulb 198 at the end of theimaging shaft 122. The bulb 198 can be made of the same material as theimaging shaft 122, such as stainless steel. The bulb 198 can include amirror 199 oriented at an angle (such as a 30-60 degree angle, e.g., 45degrees) with respect to the central axis of the fiber 197 such thatlight coming out of the fiber 197 will bounce off the mirror 197 andinto the adjacent tissue. The bulb 198 can include glue therein to holdthe distal end of the optical fiber 197 in place. The glue can have arefractive index configured to be appropriately mismatched with therefractive index of the fiber, as described in U.S. patent applicationSer. No. 12/790,703, titled “OPTICAL COHERENCE TOMOGRAPHY FOR BIOLOGICALIMAGING,” filed May 28, 2010, Publication No. US-2010-0305452-A1; andInternational Patent Application titled “OPTICAL COHERENCE TOMOGRAPHYWITH GRADED INDEX FIBER FOR BIOLOGICAL IMAGING,” filed herewith, both ofwhich are incorporated by reference in their entireties. Further, theglue can have a meniscus shape along its outer edge, as described inInternational Patent Application titled “OPTICAL COHERENCE TOMOGRAPHYWITH GRADED INDEX FIBER FOR BIOLOGICAL IMAGING,” filed herewith, alreadyincorporated by reference herein. The meniscus shape can advantageouslyensure that the light reflected back from the surface of the glue andback into the fiber 197 is significantly less than the light referenced.

The bulb 198 can further include an imaging window 107 therein alignedwith the mirror 199 such that the light bouncing off the mirror cantravel therethrough into the tissue. In some embodiments, the bulb 198can include a second hole 189 therein that is proximal to the window107. The second hole 189 can be configured to allow for the placement ofadditional glue to hold the fiber 197 in place.

Referring to FIGS. 1B and 1D-E, in some embodiments, the bulb 198 caninclude a cutter 103 connected to the distal end thereof. The cutter canbe configured, for example, to separate, dissect, or shred tissue. Asshown in FIG. 1B, the cutter 103 can have proximal end oriented an angleso as to support the angled mirror 199. Further, the cutter 103 can havea distal sharp cutting edge that extends out of a distal hole 171 in thebulb 198. In some embodiments, the cutter 103 can include multiple sharpflutes that come to a point in the center of the device. Two exemplarycutters 103 a, 103 b are shown in FIGS. 1D and 1E. The cutter 103 a ofFIG. 1D includes two spiral flutes while the cutter 103 b of FIG. 1Dincludes four spiral flutes.

The imaging shaft 122, and thus the optical fiber 197, can be configuredto rotate at high speeds, such as greater than 1,000 rpm, in a singledirection to provide OCT imaging around the inner circumference of thevessel. Such high speed rotation in a single direction (as opposed torequiring rotation alternately in both directions to manage the opticalfiber) allows for the gathering of image data more quickly, therebyproviding more accurate and up-to-date images during use of the device100. For example, images can be generated at a rate of greater than 10frames per section (fps), such as greater than 10 fps, such asapproximately 16.67 fps. In an exemplary embodiment, the rate of Lasersweep, such as approximately 20 KHz, can be configured to keep up withat 16.67 frames per second with about 1200 lines per frame.

The catheter 100 can further include a sheath 111, such as a sheath thatis less than 0.060″ in diameter, such as less than 0.050″ in diameter.The sheath 111 can extend annularly around the imaging shaft 197. Thesheath 111 can include an optically clear annular section 121 (e.g.,optically transparent at a wavelength of 1300 nm) at the distal endthereof, as shown in FIGS. 2A-2B. The optically clear annular section121 can be made, for example, of tecothane or fluorinated ethylenepropylene (FEP). In some embodiments, the optically clear annularsection 121 can have a refractive index of between 1.35 and 1.45 that isclose to the refractive index of saline, thereby reducing theback-reflection caused when saline is flushed through the sheath 111.The optically clear annular section 121 can advantageously allow forimaging with the OCT fiber 197 without extending the imaging shaft 122out of the sheath 111, thereby allowing for imaging without cutting.Thus, the imaging shaft 197 can rotate within the sheath 111 and moveaxially (proximally and distally) within the sheath 111. Allowing theimaging shaft 122 to rotate and translate within the sheath 111advantageously allows such actions to occur without changing theposition of the sheath 111 when in use within a vessel.

Referring to FIGS. 2A-2B, the catheter 100 can further include aguidewire lumen 180, which can be a monorail extending along the distalend of the sheath 111. The guidewire lumen 180 can have an innerdiameter, for example, of 0.010″ to 0.020″, such as approximately 0.016″in diameter, such as to hold, for example, a 0.014″ guidewire. Theguidewire lumen 180 can be made, for example, of polyimide. In otherembodiments, the catheter 100 can be fabricated or used without aguidewire lumen. For example, the catheter 100 (including the sheath111) can be inserted into the vessel, tunneled through an occlusionthrough the use of the cutter 103, and then the imaging shaft 122 can beremoved, leaving the sheath in place. A guidewire could then be insertedthrough the sheath 111 to get the guidewire across the occlusion.

Advantageously, because the optical fiber 197 runs through the center ofthe device 100, the device 100 can be small in diameter. For example,the outer diameter of the device 100 (including the sheath and monorail)can be less than 0.10″, such as less than 0.08″, such as less than0.07″, less than 0.06″, or less than 0.05″. Accordingly, the device 100can advantageously be used in small-diameter peripheral arteries andcoronary arteries.

Referring to FIGS. 2A-2B, in use, the device 100 can be inserted into avessel 215 in a passive configuration where the imaging shaft 122 andcutter 103 are entirely within the sheath 111 (as shown in FIG. 2A). Todo so, the device 100 can be extended over a guidewire that has beenplaced within the vessel (i.e., the guidewire lumen 180 can extend overthe guidewire). The imaging shaft 122 can be rotated, thereby obtainingan image with the fiber 197 through the clear annular section 121 of thesheath 111.

In some embodiments, the resulting image will have a wire artifactcaused by the guidewire obstructing the OCT beam as the imaging shaft122 is rotated. The wire artifact in the image can be used to determinethe direction to point or orient the catheter. That is, in someembodiments, the wire artifact can be used to align the device 100 witha fluoroscopic image and/or to orient a fixed jog or deflection point inthe catheter that has a set orientation relative to the guidewire lumen.Alignment of markers with fluoroscope images and orientation of joggedportions of a catheter using markers is described further in U.S. patentapplication Ser. No. 13/433,049, titled “OCCLUSION-CROSSING DEVICES,IMAGING, AND ATHERECTOMY DEVICES,” filed Mar. 28, 2012, Publication No.US-2012-0253186-A1, the entirety of which is incorporated herein byreference.

The guidewire can then be retracted until the wire artifact in the imageis gone, thereby fully removing the guidewire from potentialentanglement with the rotating cutter 103.

The imaging shaft 122 can then be extended distally, thereby extendingthe cutter 103 distally until the cutter 103 is past the distal end ofthe sheath 111 such that the device 100 takes an active configuration(as shown in FIG. 2B). The imaging shaft 122 can then be rotated,thereby both imaging the vessel and cutting through plaque or tissue inthe vessel. The imaging shaft 122 can then be retracted into the sheath111. The guidewire can then be advanced, and the process repeated untilthe device 100 has crossed the occlusion.

The rotation or translation of the imaging shaft 122 can be controlledthrough a handle attached the device 100. An exemplary handle 300 isshown in FIGS. 3A-3B. The handle 300 can include a rotational torqueknob 311 attachable to the sheath 111 and configured to provide torqueto the sheath 111. In some embodiments, the handle 300 can include aflush port, such as an RHV style flush port. The handle 300 can furtherinclude a mechanism, such as a fiber optic rotary junction, thereinconfigured to allow for rotation of the shaft 122 and optical fiber 197without rotating the fiber from the light source. Further, the handle300 (or the catheter 100) can be configured to be attached to a drivesystem, such as through an optical connector 313. The drive system caninclude a rotary optical junction configured to rotate the fiber.Exemplary drive systems that could be used in conjunction with thedevices herein are described in U.S. patent application Ser. No.13/654,357, titled “ATHERECTOMY CATHETERS AND NON-CONTACT ACTUATIONMECHANISM FOR CATHETERS,” filed Oct. 17, 2012 and International PatentApplication titled “ATHERECTOMY CATHETER DRIVE ASSEMBLIES,” filedherewith, each incorporated herein by reference in its entirety.

In some embodiments, the device 100 can be fabricated without the cutter103, and the device 100 can instead be used as an imaging guidewire,imaging wire, or imaging component that can be placed within anotherdevice, such as an occlusion crossing device, atherectomy device, guidecatheter, guiding sheath, over-the-wire balloon catheter, or supportcatheter, to provide imaging during procedures. In such instances, thedevice 100 could be used with the sheath 111 or without (and the devicein which device 100 is inserted could act as a sheath). Further, in suchinstances, the catheter within which the device 100 is placed caninclude a cutter. Exemplary devices with which the device 100 could beused as an imaging guidewire or imaging component are described in: U.S.patent application Ser. No. 12/689,748, titled “GUIDEWIRE POSITIONINGCATHETER,” filed Jan. 19, 2010, Publication No. US-2010-0274270-A1; U.S.patent application Ser. No. 12/108,433, titled “CATHETER SYSTEM ANDMETHOD FOR BORING THROUGH BLOCKED VASCULAR PASSAGES,” filed Apr. 23,2008, now U.S. Pat. No. 8,062,316; U.S. Patent Application No.12/829,267, titled “CATHETER-BASED OFF-AXIS OPTICAL COHERENCE TOMOGRAPHYIMAGING SYSTEM,” filed Jul. 1, 2010, Publication No. US-2010-0021926-A1;U.S. patent application Ser. No. 13/433,049, titled “OCCLUSION-CROSSINGDEVICES, IMAGING, AND ATHERECTOMY DEVICES,” filed Mar. 28, 2012,Publication No. US-2012-0253186-A1; International Patent Applicationtitled “OCCLUSION-CROSSING DEVICES,” filed herewith; U.S. patentapplication Ser. No. 12/829,277, titled “ATHERECTOMY CATHETER WITHLATERALLY-DISPLACEABLE TIP,” filed Jul. 1, 2010, Publication No.US-2011-0004107-A1; U.S. patent application Ser. No. 13/175,232, titled“ATHERECTOMY CATHETERS WITH LONGITUDINALLY DISPLACEABLE DRIVE SHAFTS,”filed Jul. 1, 2011, Publication No. US-2012-0046679-A1; U.S. patentapplication Ser. No. 13/654,357, titled “ATHERECTOMY CATHETERS ANDNON-CONTACT ACTUATION MECHANISM FOR CATHETERS,” filed Oct. 17, 2012;U.S. patent application No. 13/675,867, titled “OCCLUSION-CROSSINGDEVICES, ATHERECTOMY DEVICES, AND IMAGING,” filed Nov. 13, 2012;International Patent Application titled “ATHERECTOMY CATHETERS WITHIMAGING,” filed herewith; International Patent Application titled“BALLOON ATHERECTOMY CATHETERS WITH IMAGING,” filed herewith, theentireties of which are incorporated herein by reference.

In some embodiments, an occlusion crossing device can include astationary optical fiber for optical coherence tomography imaging.

For example, referring to FIG. 4A, an occlusion crossing device 400 caninclude a hollow rotatable imaging shaft 422. The rotatable imagingshaft 422 can be made of a coiled structure that can be optimized (suchas the number of filars or the filar size) to provide the desiredstiffness.

The occlusion crossing device 400 can further include an imagingelement. Thus, an optical fiber 497 can extend through the hollowrotatable imaging shaft 422 so as to extend substantially along thecentral axis of the device 400. The optical fiber 497 can be configuredto as to stay stationary during rotation of the imaging shaft 422. Forexample, the optical fiber 492 can be attached to a bearing at thedistal end of the imaging shaft 422.

A cutter 403 can be attached to the imaging shaft 422, such as through aconnecting collar 433. The cutter 403 can include a fluted distal end412 configured to bore through tissue. Further, the cutter 403 caninclude a mirror 499 affixed to the proximal end thereof at an angle,such as between 35 and 55 degrees, e.g., 45 degrees, relative to thecentral axis of the fiber 497.

The imaging shaft 422 can further include an imaging window 407 therein.The imaging window 407 can be placed in such a location as to allow thelight deflected off of the mirror 499 to travel through the window 407into adjacent tissue.

The imaging shaft 422 can be configured to rotate, thereby rotating thecutter 403, including the distal cutting edge 412 (to cut tissue) aswell as the mirror 499. By rotating the mirror 499, the beam travelingthrough the fiber 497 will bounce off the mirror 499 and be sent into,and received back from, areas all around the circumference of the vesselin which the device 400 is placed.

Advantageously, by rotating the mirror 499 rather than the optical fiber497, complicated fiber management mechanisms are eliminated. Moreover,the imaging shaft 422 can be rotated at high speeds, such as greaterthan 1,000 rpm, to provide better drilling with the cutting edge 412 aswell as higher imaging rates, such as rates of greater than 10 framesper section (fps), such as greater than 10 fps, such as approximately16.67 fps. In an exemplary embodiment, the rate of Laser sweep, such asapproximately 20 KHz, can be configured to keep up with at 16.67 framesper second with about 1200 lines per frame. Furthermore, by having thefiber 497 extend through the center of the device 400, the device 400can advantageously be less than 0.03″ in diameter, such as less than0.02″ in diameter, such as approximately 0.018″ in diameter.Accordingly, the device 400 can advantageously be used in small-diameterperipheral arteries and coronary arteries.

In some embodiments, referring to FIG. 4A, the device 400 can include anouter sheath 411 therearound. The outer sheath 411 can be stationaryrelative to the rotatable imaging shaft 422, thereby making it easierfor a user to hold onto the device. In some embodiments, the outersheath can be attached to the imaging shaft 422, such as through abearing. In other embodiments, the outer sheath 411 can be unattached tothe remainder of the device. In some embodiments, the outer sheath 411can include a clear annular section similar to the annular section 121described above with respect to FIGS. 1A-2B.

In some embodiments, the device 400 can further include a monorailguidewire lumen similar to the device 100 described above.

The device 400 can be attached to a drive system to provide a lightsource for OCT imaging and/or to provide torque for rotation of theimaging shaft.

In some embodiments, an occlusion-crossing device can include adeflectable tip configured to protect the distal tip when in use.

For example, referring to FIGS. 5A-5E, an occlusion-crossing device 500can include a catheter body 501, a cutter 503, and a deflectable distaltip 505 at the distal end. The catheter body 501 can include an outershaft 511 and an imaging shaft 513 extending therein. As described abovewith respect to devices 100 and 400, the device 500 can include animaging element 492, such as an optical fiber extending through theimaging shaft 513 so as to run substantially along the central axis ofthe catheter body 501. A mirror 599 oriented at 35-55 degrees, such as45 degrees, can be configured to project the light into the tissue at a90 degree angle relative to the optical fiber. The cutter 503 can beattached to the imaging shaft 513. The cutter 503 can include aperforating tip 572 extending off of the distal end thereof. Theperforating tip 572 can be configured to penetrate tissue as it isadvanced and/or rotated. For example, the perforating tip 572 can beshaped as a fluted end mill or drill or a plurality of shape-set sharpwhiskers. The perforating tip 472 can have a diameter that is smallerthan the diameter of the rest of the cutter 503 and/or the elongate body501, thereby advantageously providing a sharper or more pronounced pointfor drilling. The size of the perforating tip 572 can further beapproximately the size of the guidewire 590, thereby helping to providea hole through which the guidewire can extend.

In some embodiments, a guidewire lumen 580, such as a monorail guidewirelumen 580 can run along the outside of the device to hold a guidewire590. Further, in some embodiments, as shown in FIGS. 5A-5C, theguidewire lumen 580 can extend through the distal tip 505 and extend outof the distal-most end 551 of the distal tip 505.

The deflectable distal tip 505 can be attached to the outer shaft 511 ata hinge point 583, such as at a hinge pin. The deflectable distal tip505 can have a wedged distal edge 555, best shown in FIGS. 5D-5E. Thewedged distal edge 555 can advantageously be aligned with a hard ordense occlusion such that the distal-most end 551 of the distal tip 505is oriented partially around the occlusion (along the side of thevessel). When the distal tip 505 is deflected, this position can beenhanced, allowing the guidewire lumen 550 and guidewire 590 to aimaround the occlusion. Using a guidewire 590 having a curved distal end,as shown in FIG. 590, can help the guidewire slide along the occlusioneven as the distal-most edge 551 of the tip 505 (and thus the guidewirelumen 580) is pointed towards the vessel wall.

Further, the deflectable distal tip can have a cut-out 587 configured tohouse the perforating tip 572 therein. The deflectable distal tip can bedeflected, for example, by pulling or pushing on the drive shaft 513,similar to embodiments described in International Patent Applicationtitled “BALLOON ATHERECTOMY CATHETERS WITH IMAGING,” filed herewith;U.S. patent application Ser. No. 13/175,232, titled “ATHERECTOMYCATHETERS WITH LONGITUDINALLY DISPLACEABLE DRIVE SHAFTS,” filed Jul. 1,2011, Publication No. US-2012-0046679-A1; U.S. patent application Ser.No. 12/829,277, titled “ATHERECTOMY CATHETER WITH LATERALLY-DISPLACEABLETIP,” filed Jul. 1, 2010, Publication No. US-2011-0004107-A1;International Patent Application titled “ATHERECTOMY CATHETERS WITHIMAGING,” all of which are incorporated by reference herein. Thedeflectable distal tip 505 can thus have a closed configuration, asshown in FIG. 5A, wherein the deflectable tip 505 covers the perforatingtip 572, and an open configuration where the deflectable tip 505 exposesthe perforating tip 572.

In some embodiments, the imaging shaft 513 can be moved proximally anddistally.

Distal extension of the imaging shaft 513 when the deflectable distaltip 505 is deflected can advantageously extend the perforating tip 572past the distal end of the tip 505 to provide for drilling with thedeflectable tip 572 out of the way.

Because the optical fiber runs through the center of the device, theimaging shaft 513 can advantageously be rotated at high speeds in asingle direction, such as greater than 1,000 rpm, to provide betterdrilling with the cutting edge 412 as well as higher imaging rates, asdescribed above with respect to devices 100 and 400. Furthermore, byhaving the fiber of the imaging sensor 592 extend through the center ofthe device 500, the device 500 can advantageously be less than 0.10″,such as less than 0.08″, such as less than 0.07″, less than 0.06″, orless than 0.05″. Accordingly, the device 500 can advantageously be usedin small-diameter peripheral arteries and coronary arteries.

In operation, the device 500 can be advanced through the vasculaturewith the tip 505 in the non-deflected position (shown in FIG. 5A). Atthe target lesion or CTO, the device 500 can continue to be advanceduntil an obstruction is encountered that cannot be passed by the device500. At this point, the imaging sensor 592 can be used to identifystructures in the vessel that could potentially be easier to passthrough (non-ossified material). The device 500 can then be re-orientedthe tip 505 deflected (as shown in FIG. 5C) to facilitate ‘aiming’ theguide wire lumen 580 in the direction of the more penetrable structure.The guide wire 590 can then be advanced along a new trajectory whilebeing supported by the guide wire lumen 580. Once the guide wire 590 hastraversed some distance through the obstacle, the tip 505 of the devicecan be returned to the normal (non-deflected) position to facilitatepassage over the guide wire. If further obstacles are encountered, theprocess can be repeated until complete passage of the lesion or CTO hadbeen achieved. In embodiments where the distal tip 503 includes aperforating tip 572, a hole can be created in the occlusion to help passthe guidewire therethrough.

Any of the catheters described herein can be shape-set or includeshape-set features to enhance trackability and navigability.

As used herein, an imaging element can include the OCT optical fiber,such as the distal end of the optical fiber, as well as the mirror andadhesive used to hold the mirror and optical fiber in place.

As described above, the catheters described herein can include opticalcoherence tomography imaging, such as common path OCT. Such OCT systemsare described in U.S. patent application Ser. No. 12/829,267, titled“CATHETER-BASED OFF-AXIS OPTICAL COHERENCE TOMOGRAPHY IMAGING SYSTEM,”filed Jul. 1, 2010, Publication No. US-2010-0021926-A1; U.S. patentapplication Ser. No. 12/790,703, titled “OPTICAL COHERENCE TOMOGRAPHYFOR BIOLOGICAL IMAGING,” filed May 28, 2010, Publication No.US-2010-0305452-A1; and International Patent Application titled “OPTICALCOHERENCE TOMOGRAPHY WITH GRADED INDEX FIBER FOR BIOLOGICAL IMAGING,”filed herewith, all of which are incorporated by reference in theirentireties. Alternatively, other types of imaging could be used with thecatheters described herein. For example, the devices described hereincould be configured to work with infrared spectroscopy or ultrasound.

Additional details pertinent to the present invention, includingmaterials and manufacturing techniques, may be employed as within thelevel of those with skill in the relevant art. The same may hold truewith respect to method-based aspects of the invention in terms ofadditional acts commonly or logically employed. Also, it is contemplatedthat any optional feature of the inventive variations described may beset forth and claimed independently, or in combination with any one ormore of the features described herein. Likewise, reference to a singularitem, includes the possibility that there are a plurality of the sameitems present. More specifically, as used herein and in the appendedclaims, the singular forms “a,” “and,” “said,” and “the” include pluralreferents unless the context clearly dictates otherwise. It is furthernoted that the claims may be drafted to exclude any optional element. Assuch, this statement is intended to serve as antecedent basis for use ofsuch exclusive terminology as “solely,” “only” and the like inconnection with the recitation of claim elements, or use of a “negative”limitation. Unless defined otherwise herein, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs. The breadth of the present invention is not to be limited bythe subject specification, but rather only by the plain meaning of theclaim terms employed.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present.

Although described or shown with respect to one embodiment, the featuresand elements so described or shown can apply to other embodiments. Itwill also be appreciated by those of skill in the art that references toa structure or feature that is disposed “adjacent” another feature mayhave portions that overlap or underlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements, these features/elements should not be limitedby these terms, unless the context indicates otherwise. These terms maybe used to distinguish one feature/element from another feature/element.Thus, a first feature/element discussed below could be termed a secondfeature/element, and similarly, a second feature/element discussed belowcould be termed a first feature/element without departing from theteachings of the present invention.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

What is claimed is:
 1. An imaging device comprising: a hollow flexibleshaft having a central longitudinal axis and an imaging window therein;an optical fiber extending within the hollow flexible shaftsubstantially along the central axis, a distal tip of the optical fiberattached to the hollow flexible shaft and aligned with the imagingwindow so as to transfer an optical coherence tomography signal throughthe imaging window; and a handle attached to the hollow flexible shaftconfigured rotate the hollow flexible shaft at speeds of greater than1,000 rpm.
 2. The imaging device of claim 1, wherein the optical fiberextends substantially along the central axis for the entire length ofthe fiber.
 3. The imaging device of claim 1, wherein the device is lessthan 0.1 inches in diameter.
 4. The imaging device of claim 3, whereinthe device is less than 0.08 inches in diameter.
 5. The imaging deviceof claim 4, wherein the device is less than 0.05 inches in diameter. 6.The imaging device of claim 1, wherein the hollow flexible shaft is madeof tungsten.
 7. The imaging device of claim 1, wherein the hollowflexible shaft is made of multiple layers of wound filars.
 8. Theimaging device of claim 7, wherein the filars are counterwound.
 9. Theimaging device of claim 1, wherein the hollow flexible shaft furtherincludes a mirror therein configured to reflect light from the opticalfiber into adjacent tissue.
 10. The imaging device of claim 1, furthercomprising an outer sheath extending around the hollow flexible shaft.11. The imaging device of claim 10, wherein the outer sheath includes anoptically clear annular section at the distal end thereof. 12.-21.(canceled)
 22. A method of imaging a body lumen, the method comprising:inserting a catheter into the body lumen; inserting an imaging deviceinto a lumen of the catheter, the imaging device including a hollowflexible shaft having a central longitudinal axis with an imaging windowtherein and an optical fiber extending within the hollow flexible shaftand attached to the hollow flexible shaft , the optical fiber extendingsubstantially along the central longitudinal axis; rotating the hollowflexible shaft within the lumen of the catheter; and collecting imagesof the body lumen through the imaging window with the optical fiber. 23.The method of claim 22, wherein rotating the hollow flexible shaftwithin the lumen comprises rotating the hollow flexible shaft at speedsof greater than 1,000 rpm.
 24. The method of claim 22, whereincollecting images of the body lumen comprises collecting images of thebody lumen at rates of greater than 10 frames per minute.
 25. The methodof claim 22, wherein the body lumen is a coronary artery.
 26. The methodof claim 22, wherein the body lumen is a peripheral artery.
 27. Themethod of claim 22, wherein the catheter includes a cutter thereon, themethod further comprising cutting tissue of the body lumen with thecatheter to pass through an occlusion in the body lumen.
 28. The methodof claim 27, further comprising removing the imaging device from thelumen of the catheter and advancing a guidewire through the lumen of thecatheter after passing the cutter through the occlusion. 29-57.(canceled)